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Clinical Trial NCT07313683 (PelviRecover) for Postpartum Period, Pelvic Floor Disorders is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Therapeutic Exercise for Postpartum Recovery (PelviRecover) 84 Postpartum Exercise-Based
Clinical Trial NCT07313683 (PelviRecover) is an interventional study for Postpartum Period, Pelvic Floor Disorders and is currently not yet recruiting. Enrollment is planned to begin on 15 March 2026 and continue until the study accrues 84 participants. Led by University of Alcala, this study is expected to complete by 1 February 2029. The latest data from ClinicalTrials.gov was last updated on 9 March 2026.
Brief Summary
Pelvic floor dysfunctions (PFDs) are common conditions that affect women, especially after vaginal childbirth. These disorders can cause urinary or fecal incontinence, pain during sexual activity, and prolapse of pelvic organs, leading to a significant decrease in quality of life. Current scientific evidence shows that early and specific physiotherapy-based interventions after childbirth may help reduce the risk of d...Show More
Detailed Description
Pelvic floor dysfunctions (PFDs) are highly prevalent conditions that impose a substantial burden on women's health, particularly following vaginal childbirth. Vaginal delivery has been identified as a major risk factor due to potential trauma to the pelvic floor, including overstretching of muscles and nerves, damage to connective tissue supporting pelvic organs, and direct perineal injury. Obstetric interventions s...Show More
Official Title
Lumbopelvic Stabilization Exercises vs. Hypopressive Exercises for Postpartum Recovery: A Randomized Clinical Trial
Conditions
Postpartum PeriodPelvic Floor DisordersOther Study IDs
- PelviRecover
- CEIP/2025/3/069
NCT ID Number
Start Date (Actual)
2026-03-15
Last Update Posted
2026-03-09
Completion Date (Estimated)
2029-02
Enrollment (Estimated)
84
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Therapeutic exercise
Physical therapy
Intra-abdominal pressure
Pelvic floor
Postpartum period
Quality of life
Physical therapy
Intra-abdominal pressure
Pelvic floor
Postpartum period
Quality of life
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExperimental Group 2: Multimodal Physiotherapy (HE + PFMT + TE) Hypopressive Exercises \& Pelvic Floor Exercises \& Therapeutic Education | Therapeutic Education (TE) The participants will receive Therapeutic Education supported by audiovisual materials covering abdominopelvic anatomy and physiology, common dysfunctions, risk factors, and protective strategies, delivered through 4 face-to-face sessions of 20 minutes over the 8-week intervention period. Pelvic Floor Exercises (PFMT) The participants will attend 8 weekly 45-minute sessions (4 in person at the Research Group laboratory and 4 online via Physitrack®). They will undergo Pelvic Floor Muscle Training guided intravaginally using manometry biofeedback to improve proprioception, strength, endurance, and relaxation, and will perform the exercises at home at least four times per week. Hypopressive Exercises (HE) Participants will attend 8 weekly 45-minute sessions (4 in person at the Research Group laboratory and 4 online via Physitrack®). They will perform hypopressive exercises under transabdominal ultrasound guidance following the Caufriez method, without voluntary abdominal or pelvic floor contraction, and will perform the exercises at home at least four times per week. |
ExperimentalExperimental Group 1: Multimodal Physiotherapy (LSE + PFMT + TE) Lumbopelvic Stabilization Exercises \& Pelvic Floor Exercises \& Therapeutic Education | Therapeutic Education (TE) The participants will receive Therapeutic Education supported by audiovisual materials covering abdominopelvic anatomy and physiology, common dysfunctions, risk factors, and protective strategies, delivered through 4 face-to-face sessions of 20 minutes over the 8-week intervention period. Pelvic Floor Exercises (PFMT) The participants will attend 8 weekly 45-minute sessions (4 in person at the Research Group laboratory and 4 online via Physitrack®). They will undergo Pelvic Floor Muscle Training guided intravaginally using manometry biofeedback to improve proprioception, strength, endurance, and relaxation, and will perform the exercises at home at least four times per week. Lumbopelvic Stabilization Exercises (LSE) Participants will attend 8 weekly 45-minute sessions (4 in person at the Research Group laboratory and 4 online via Physitrack®). They will perform lumbopelvic stabilization exercises guided by transabdominal ultrasound to ensure correct activation of trunk stabilizing muscles, primarily the transversus abdominis and pelvic floor muscles. Exercises will emphasize coordination of the lumbar multifidus, transversus abd...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Health-related quality of life (HRQoL) | Self-administration of the PFDI-20 questionnaire, which evaluates urogenital, anorectal, and prolapse-related symptoms. Each subscale ranges from 0 to 100, with lower scores indicating better quality of life (less symptom distress). | Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Sexual function | Self-administration of the Female Sexual Function Index (FSFI), which assesses sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI total score ranges from 2 to 36. A cutoff score of \<27 is commonly used to indicate sexual dysfunction | Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention. |
Physical activity level | Self-administration of the International Physical Activity Questionnaire (IPAQ). This instrument estimates weekly physical activity based on energy expenditure expressed in MET·min/week, taking into account the frequency, duration, and intensity of the activities performed. It classifies individuals into three categories: low (inactive), moderate, or high. | Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention. |
Urogenital hiatus distance | 2D transperineal ultrasound (Mindray M7, Shenzhen, China): sagittal plane, measuring the distance between the inferior margin of the pubic symphysis and the anorectal angle. Measurements will be obtained at rest and during maximal pelvic floor muscle contraction. | Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention. |
Pelvic floor muscle tone and strength | Vaginal dynamometry (Pelvimetre, Phenix Vivaltis, Montpellier, France): in the lithotomy position, resting tone will be recorded as the lowest value obtained with the pelvic floor muscles relaxed, and strength will be determined as the mean of three maximal voluntary contractions. | Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention. |
Perceived self-efficacy | Self-administration of the Broome Pelvic Muscle Self-Efficacy Scale: this instrument evaluates self-efficacy expectations regarding the performance of specific pelvic floor muscle exercises and the anticipated outcomes. The maximum score is 100, indicating high self-efficacy, while scores below 33 reflect low self-efficacy. | Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention. |
Functional capacity | 30-Second Sit-to-Stand Test: records the total number of complete repetitions of standing up from and sitting down on a standard armless chair, with the arms crossed over the chest, performed within a 30-second interval. | Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- Primiparous or multiparous women with an uncomplicated vaginal delivery.
- Women between 6 and 12 weeks postpartum.
- Women who have freely read, understood, and signed the informed consent form.
- Cesarean delivery.
- Pelvic or perineal pain greater than 4/10 during physical examination.
- Clinical diagnosis of pelvic floor myofascial pain syndrome.
- Evidence of levator ani muscle avulsion.
- Third- or fourth-degree perineal tears.
- History of pelvic surgery.
- History of pelvic fractures and/or pelvic neoplasms.
- Current pregnancy.
- Neurological disorders.
- Active vaginal or urinary tract infections.
- Cognitive, auditory, or visual impairments that limit comprehension, questionnaire completion, consent, or participation in the study.
- Individuals under 18 years of age.
University of AlcalaStudy Responsible Party
Virginia Prieto Gómez, Principal Investigator, Principal Investigator, University of Alcala
Study Central Contact
Contact: Virginia Prieto Gómez, Dr., +34 918 854 828, [email protected]
1 Study Locations in 1 Countries
Madrid
Faculty of Nursing and Physiotherapy, University of Alcalá, Alcalá de Henares, Madrid, 28805, Spain
Virginia Prieto Gómez, Dr., Contact, +34 918 854 828, [email protected]
Beatriz Navarro Brazález, Dr., Contact, +34 918 854 828, [email protected]